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DRRX

Durect

$2.55

0.08 (3.24%)

07:07
01/16/20
01/16
07:07
01/16/20
07:07

Durect trading halted for FDA meeting on Posimir

Durect announced that Nasdaq has halted trading of the company's common stock today. The FDA's Anesthetic and Analgesic Drug Products Advisory Committee is holding a meeting from 8 a.m. to 5 p.m. ET to discuss Posimir, an investigational medicine for the treatment of post-surgical pain. Although the FDA considers the recommendations of the AADPAC, recommendations by the panel are non-binding, and the final decision regarding pending regulatory actions for a product is made by the FDA.

  • 16

    Jan

DRRX Durect
$2.55

0.08 (3.24%)

01/02/20
CANT
01/02/20
NO CHANGE
Target $5
CANT
Overweight
Cantor says Durect pullback improves risk/reward ahead of Posimir panel
Cantor Fitzgerald analyst Eliana Merle noted that shares of Durect have fallen by over 30% after the company reported that the Phase 2a trial of its topical formulation of DUR-928 in psoriasis did not meet its primary endpoint and the company does not plan to pursue further development in that indication. However, she said that psoriasis was not included in her base case assumptions for Durect and that liver indications alcoholic hepatitis and nonalcoholic steatohepatitis remain the company's primary focus for 928. Management noted in speaking with Merle that the biology in psoriasis is very different from AH and NASH, which have Phase 2 programs underway, the analyst added. Durect's Posimir extended release agent for postoperative pain will be reviewed by an FDA advisory committee on January 16 and Merle sees today's pullback in the stock improving the risk/reward into that panel meeting, said the analyst, who keeps an Overweight rating and $5 price target on the stock.
01/02/20
STFL
01/02/20
NO CHANGE
Target $2.1
STFL
Hold
Stifel still cautious on Durect ahead of Posimir panel following psoriasis news
Stifel analyst Adam Walsh noted that Durect announced that the Phase 2a trial of DUR-928 in plaque psoriasis did not show a benefit over placebo and the program is discontinued, but he also noted that he had not included the psoriasis indication in his estimates going into the data release. On January 16, an advisory committee meeting for Posimir, Durect's proposed post-operative pain drug, will be hosted by the FDA, but Walsh is cautious heading into that meeting given "Posimir's checkered history with multiple CRLs," he tells investors. Walsh keeps a Hold rating and $2.10 price target on Durect shares, which are down $1.23, or 32%, to $2.57 in afternoon trading.
01/03/20
HCWC
01/03/20
NO CHANGE
Target $5.5
HCWC
Buy
Durect pullback on psoriasis failure 'wholly unwarranted,' says H.C. Wainwright
H.C. Wainwright analyst Ed Arce said yesterday's substantial decline in Durect shares was "wholly unwarranted" given that he believes the trial failure of topical DUR-928 in mild-to-moderate plaque psoriasis to be a "non-event" since psoriasis was "not in anyone's model." He also sees no psoriasis read-through to other DUR-928 programs in alcoholic hepatitis or nonalcoholic steatohepatitis, Arce added. The analyst, who expects Durect shares to quickly recover from the market's "knee-jerk reaction," keeps a Buy rating on the stock and raised his price target to $5.50 from $4 after revisiting his alcoholic hepatitis model.
01/14/20
CANT
01/14/20
NO CHANGE
Target $5
CANT
Overweight
Durect briefing docs contain 'few surprises,' says Cantor Fitzgerald
Cantor Fitzgerald analyst Eliana Merle sees "few surprises" in the FDA's briefing docs ahead of the upcoming committee meeting for Durect's Posimir extended-release bupivacaine product for post-operative pain. The analyst sees investors being focused on the outcome of the voting question, asking if the company "submitted adequate efficacy and safety data to support approval of Posimir, bupivacaine extended-release solution, 660 mg/5 mL (132 mg/mL), for the proposed indication of single-dose instillation into the surgical site to produce post-surgical analgesia." These documents are in line with prior comments from the FDA and Durect regarding the submission, Merle tells investors in a research note. The analyst points out that Posimir is not included in her base case for Durect. As such, any eventual program revenues represent upside to her current valuation. If approved, Merle expects Durect to license Posimir. She has an Overweight rating on the shares with a $5 price target. The stock in early trading is up 1c to $2.45.

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  • 05

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